Medical device manufacturer

Valleylab,A Division of Tyco Healthcare Group LP

Valleylab,A Division of Tyco Healthcare Group LP holds 106 FDA 510(k) clearances across 15 product codes. Median elapsed review time is 62 days. openFDA lists 2 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 106
Product codes: 15
Median review: 62 days
Recall records: 2

How does FDA spell Valleylab,A Division of Tyco Healthcare Group LP?

FDA publishes this company under 4 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.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published it	Dataset	Matched by
Valleylab	device/510k	normalised
Valleylab, Inc	device/recall	normalised
Valleylab, Inc.	device/510k	normalised
Valleylab,A Division of Tyco Healthcare Group LP	device/510k	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 Valleylab,A Division of Tyco Healthcare Group LP file in?

15 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
GEI	Electrosurgical, Cutting & Coagulation & Accessories	71	56 days	16 October 2009
LFL	Instrument, Ultrasonic Surgical	9	102 days	6 July 1998
FRN	Pump, Infusion	7	53 days	28 July 1989
FPA	Set, Administration, Intravascular	4	47 days	21 October 1988
HGI	Electrocautery, Gynecologic (And Accessories)	3	238 days	7 September 1993
GEH	Unit, Cryosurgical, Accessories	2	30 days	20 March 1981
LBK	Neurosurgical Ultrasonic Instruments	2	43 days	2 December 1988
BWA	Unit, Electrosurgical And Coagulation, With Accessories	1	21 days	14 December 1987
DRX	Electrode, Electrocardiograph	1	33 days	25 January 1989
FYD	Apparatus, Exhaust, Surgical	1	110 days	29 June 1998
GFI	Osteotome, Manual	1	125 days	2 November 1993
GXY	Electrode, Cutaneous	1	38 days	18 September 1986
HGZ	Heater, Perineal, Direct Contact	1	703 days	25 March 1994
KGF	Adhesive, Tissue For Aneurysmorrhaphy	1	148 days	1 June 1989
NEY	System, Ablation, Microwave And Accessories	1	129 days	27 April 2006

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 2026-08-11T14:48:53Z

Has Valleylab,A Division of Tyco Healthcare Group LP had a recall?

openFDA lists 2 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-1121-03TerminatedHAM16 July 2003
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
Z-1122-03TerminatedHAM16 July 2003
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.

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 2026-08-11T14:48:53Z

What has Valleylab,A Division of Tyco Healthcare Group LP cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K092879	LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER	GEI	16 October 2009	28
K070446	COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL	GEI	2 May 2007	76
K070162	FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS	GEI	6 March 2007	48
K063195	LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044	GEI	29 November 2006	40
K053535	VIVAWAVE MICROWAVE ABLATION SYSTEM	NEY	27 April 2006	129
K053290	COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES	GEI	15 March 2006	110
K052796	COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES	GEI	3 February 2006	123
K051644	VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR	GEI	11 August 2005	52
K051627	VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT	GEI	22 July 2005	32
K043273	LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS	GEI	5 January 2005	40

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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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.