FDA 510(k)

NU-SPEC D

K-Number: K012859 · 2001-10-26

Decision Date2001-10-26

Product CodeHIB

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

NU-SPEC D is the device name listed in this FDA 510(k) record. The listed applicant is Sol Weiss MD, Inc.. It received FDA 510(k) clearance on 2001-10-26 under 510(k) number K012859. 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 NU-SPEC D?

NU-SPEC D is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is Sol Weiss MD, Inc.. The 510(k) number is K012859.

When did NU-SPEC D receive FDA 510(k) clearance?

NU-SPEC D received FDA 510(k) clearance on 2001-10-26, under 510(k) number K012859.

Who is the listed applicant for NU-SPEC D?

The FDA 510(k) record lists Sol Weiss MD, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NU-SPEC D?

The FDA product code for NU-SPEC D is HIB.

Other records listing Sol Weiss MD, 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.

K020959GLO-SPEC I, II AND III K013817GLO-SPEC

Related Devices (Code: HIB)

K252208JFord Speculum Sleeve™Ford Medtech, LLC K130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLC K120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI Ltda K092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

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.