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FDA 510(k)

WALLACH FLEXIBLE ENDOMETRIAL SAMPLER

K-Number: K902693 · 1991-01-31

ApplicantWallach Surgical Devices, Inc.
Decision Date1991-01-31
Product CodeHFF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WALLACH FLEXIBLE ENDOMETRIAL SAMPLER 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 1991-01-31 under 510(k) number K902693. The device is classified under product code HFF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLACH FLEXIBLE ENDOMETRIAL SAMPLER?

WALLACH FLEXIBLE ENDOMETRIAL SAMPLER is a medical device that received FDA 510(k) clearance on 1991-01-31. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K902693.

When did WALLACH FLEXIBLE ENDOMETRIAL SAMPLER receive FDA 510(k) clearance?

WALLACH FLEXIBLE ENDOMETRIAL SAMPLER received FDA 510(k) clearance on 1991-01-31, under 510(k) number K902693.

Who is the listed applicant for WALLACH FLEXIBLE ENDOMETRIAL SAMPLER?

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 FLEXIBLE ENDOMETRIAL SAMPLER?

The FDA product code for WALLACH FLEXIBLE ENDOMETRIAL SAMPLER is HFF.

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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: HFF)

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.

K041237ECHOSAMPLERGynetics Medical Products NVK903002PROBET (TM)Gynopharma, Inc.K831212ENDOSCANNAxcan Scientific Corp.K820641ACCURETTEAxcan Scientific Corp.

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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