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FDA 510(k)

WALLACH ZOOM COLPOSCOPE

K-Number: K853389 · 1985-11-19

ApplicantWallach Surgical Devices, Inc.
Decision Date1985-11-19
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WALLACH ZOOM COLPOSCOPE 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 1985-11-19 under 510(k) number K853389. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLACH ZOOM COLPOSCOPE?

WALLACH ZOOM COLPOSCOPE is a medical device that received FDA 510(k) clearance on 1985-11-19. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K853389.

When did WALLACH ZOOM COLPOSCOPE receive FDA 510(k) clearance?

WALLACH ZOOM COLPOSCOPE received FDA 510(k) clearance on 1985-11-19, under 510(k) number K853389.

Who is the listed applicant for WALLACH ZOOM COLPOSCOPE?

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 ZOOM COLPOSCOPE?

The FDA product code for WALLACH ZOOM COLPOSCOPE is HEX.

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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 SPECULUMK991669PMS 750 FINGERSWITCHK983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)

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Related Devices (Code: HEX)

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.

K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd.K190187Gynescope SystemIllumigyn , Ltd.K182764Biop Digital ColposcopeBiop Medical , Ltd.K181034Pocket Colposcope SystemHadleigh Health Technologies, LLCK170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , 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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