FDA 510(k)

WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

K-Number: K983208 · 1999-02-22

Decision Date1999-02-22

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR 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 1999-02-22 under 510(k) number K983208. 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 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR?

WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 1999-02-22. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K983208.

When did WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR receive FDA 510(k) clearance?

WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 1999-02-22, under 510(k) number K983208.

Who is the listed applicant for WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR?

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 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR?

The FDA product code for WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR is GEI.

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Other records listing Wallach Surgical Devices, Inc. as applicant

K021224ENDOCERVICAL BLOCK NEEDLE K020711WALLACH LOOP ELECTRODE K000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR K992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM K991669PMS 750 FINGERSWITCH K983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)

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Official Source

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