Cleared Traditional

K951898 - VERSA-VU

K951898 is an FDA 510(k) clearance for VERSA-VU, manufactured by CooperSurgical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K951898 · CooperSurgical, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
231d
Days
Class 2
Risk

K951898 is an FDA 510(k) clearance for the VERSA-VU. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 231 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all CooperSurgical, Inc. devices

FDA 510(k) Submission Details - K951898

510(k) Number K951898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date December 11, 1995
Days to Decision 231 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 160d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIB Speculum, Vaginal, Nonmetal

All 29
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K951898.
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K971979 · Playtex Products, Inc. · Sep 1997
NYLON COATED SPECULA
K925501 · Zinnanti Surgical Instruments, Inc. · Jun 1997
EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
K963377 · North Eos Industries, Inc. · Oct 1996
KLEENSPEC
K941272 · Welch Allyn, Inc. · Aug 1994
THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV
K930954 · Cabot Medical Corp. · Jun 1994
DISPOSABLE PLASTIC VAGINAL SPECULA
K926536 · Thomasville Medical Assoc. · Feb 1994