Medical device manufacturer
Stryker Endoscopy
Stryker Endoscopy holds 101 FDA 510(k) clearances across 28 product codes. Median elapsed review time is 87 days. openFDA lists 278 recall records naming the company. FDA publishes it under 5 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 101
- Product codes
- 28
- Median review
- 87 days
- Recall records
- 278
How does FDA spell Stryker Endoscopy?
FDA publishes this company under 5 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| STRYKER ENDOSCOPY | device/registrationlisting | normalised |
| Stryker Endoscopy | device/recall | normalised |
| Stryker Endoscopy | device/510k | normalised |
| Stryker Endoscopy | device/registrationlisting | normalised |
| Stryker Endoscopy | device/enforcement | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Stryker Endoscopy file in?
28 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 25 | 82 days | |
| HRX | Arthroscope | 11 | 153 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 10 | 57 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 134 days | |
| HWC | Screw, Fixation, Bone | 7 | 145 days | |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 4 | 28 days | |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 3 | 44 days | |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 | 153 days | |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 3 | 90 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 120 days | |
| HIH | Hysteroscope (And Accessories) | 3 | 90 days | |
| JDW | Pin, Fixation, Threaded | 3 | 71 days | |
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | 2 | 63 days | |
| OWN | Confocal Optical Imaging | 2 | 29 days | |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 73 days | |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 132 days | |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 | 263 days | |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 25 days | |
| FSS | Light, Surgical, Floor Standing | 1 | 39 days | |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 130 days | |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 76 days | |
| GDW | Staple, Implantable | 1 | 223 days | |
| GWG | Endoscope, Neurological | 1 | 198 days | |
| HTY | Pin, Fixation, Smooth | 1 | 58 days | |
| IZI | System, X-Ray, Angiographic | 1 | 59 days |
Showing the 25 they file in most, of 28.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Stryker Endoscopy had a recall?
openFDA lists 278 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1566-2016Class IITerminatedHIF
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
Z-1831-2015Class IITerminatedGEI
Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
Z-0592-2015Class IITerminated
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Z-0593-2015Class IITerminated
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Z-0594-2015Class IITerminated
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Showing the 5 most recently initiated of 278.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Stryker Endoscopy cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253602 | Precision S 4K Sinuscope | GWG | 198 | |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | IZI | 59 | |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | GCJ | 28 | |
| K260108 | L12 LED Light Source with AIM | OWN | 29 | |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | GCJ | 29 | |
| K253888 | MOLLI 2 System | NEU | 27 | |
| K252010 | SPY Laparoscope | GCJ | 27 | |
| K252012 | SPY Cystoscope/Hysteroscope | HIH | 21 | |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | MAI | 87 | |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor | MAI | 86 |
Source: openFDA device/510k · retrieved
Where is Stryker Endoscopy registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Stryker Endoscopy files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.