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FDA 510(k)

ZOMED MODEL 10 CAUTERY BIOPSY DEVICE

K-Number: K951659 · 1995-06-19

ApplicantZomed Intl.
Decision Date1995-06-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZOMED MODEL 10 CAUTERY BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Zomed Intl.. It received FDA 510(k) clearance on 1995-06-19 under 510(k) number K951659. 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 ZOMED MODEL 10 CAUTERY BIOPSY DEVICE?

ZOMED MODEL 10 CAUTERY BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1995-06-19. The listed applicant is Zomed Intl.. The 510(k) number is K951659.

When did ZOMED MODEL 10 CAUTERY BIOPSY DEVICE receive FDA 510(k) clearance?

ZOMED MODEL 10 CAUTERY BIOPSY DEVICE received FDA 510(k) clearance on 1995-06-19, under 510(k) number K951659.

Who is the listed applicant for ZOMED MODEL 10 CAUTERY BIOPSY DEVICE?

The FDA 510(k) record lists Zomed Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOMED MODEL 10 CAUTERY BIOPSY DEVICE?

The FDA product code for ZOMED MODEL 10 CAUTERY BIOPSY DEVICE is GEI.

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Other records listing Zomed Intl. 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.

K964286ZOMED PASSIVE TEMPERATURE PROBEK962692ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBEK960695MODEL 200C ELECTROSURGICAL PROBEK960694ZOMED 30F ELECTROSURGICAL PROBEK954965ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBESK952072ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE

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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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