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FDA 510(k)

WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM

K-Number: K992736 · 1999-09-29

ApplicantWallach Surgical Devices, Inc.
Decision Date1999-09-29
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM 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 1999-09-29 under 510(k) number K992736. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM?

WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 1999-09-29. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K992736.

When did WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM receive FDA 510(k) clearance?

WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM received FDA 510(k) clearance on 1999-09-29, under 510(k) number K992736.

Who is the listed applicant for WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM?

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'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM?

The FDA product code for WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM is HIB.

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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 GENERATORK991669PMS 750 FINGERSWITCHK983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)K984306`THE INSEMINATOR' (PROPOSED)

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Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

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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