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FDA 510(k)

PMS 750 FINGERSWITCH

K-Number: K991669 · 1999-08-12

ApplicantWallach Surgical Devices, Inc.
Decision Date1999-08-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PMS 750 FINGERSWITCH is the device name listed in this FDA 510(k) record. The listed applicant is Wallach Surgical Devices, Inc.. It received FDA 510(k) clearance on 1999-08-12 under 510(k) number K991669. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMS 750 FINGERSWITCH?

PMS 750 FINGERSWITCH is a medical device that received FDA 510(k) clearance on 1999-08-12. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K991669.

When did PMS 750 FINGERSWITCH receive FDA 510(k) clearance?

PMS 750 FINGERSWITCH received FDA 510(k) clearance on 1999-08-12, under 510(k) number K991669.

Who is the listed applicant for PMS 750 FINGERSWITCH?

The FDA 510(k) record lists Wallach Surgical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMS 750 FINGERSWITCH?

The FDA product code for PMS 750 FINGERSWITCH is GEI.

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Other records listing Wallach Surgical Devices, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021224ENDOCERVICAL BLOCK NEEDLEK020711WALLACH LOOP ELECTRODEK000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORK992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUMK983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)K984306`THE INSEMINATOR' (PROPOSED)

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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