Cleared Traditional

K926595 - OWENS BIOPSY FORCEPS

K926595 is an FDA 510(k) clearance for OWENS BIOPSY FORCEPS, manufactured by Owens Industries, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HFB cleared through the Traditional 510(k) pathway after a 623-day FDA review.

K926595 · Owens Industries, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
623d
Days
Class 1
Risk

K926595 is an FDA 510(k) clearance for the OWENS BIOPSY FORCEPS. Classified as Forceps, Biopsy, Gynecological (product code HFB), Class I - General Controls.

Submitted by Owens Industries, Inc. (Oak Creek, US). The FDA issued a Cleared decision on May 25, 1994 after a review of 623 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Owens Industries, Inc. devices

FDA 510(k) Submission Details - K926595

510(k) Number K926595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1992
Decision Date May 25, 1994
Days to Decision 623 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
463d slower than avg
Panel avg: 160d · This submission: 623d
Pathway characteristics
Predicate-based equivalence.

HFB Device Classification - Class 1, General Controls

Product Code HFB Forceps, Biopsy, Gynecological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HFB Forceps, Biopsy, Gynecological

All 12
Devices cleared under the same product code (HFB) and FDA review panel - the closest regulatory comparables to K926595.
SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS
K930773 · Symbiosis Corp. · Jul 1994
ROTO FIT BIOPSY FORCEPS
K926527 · Thomasville Medical Assoc. · Feb 1994
TISCHLER BIOPSY FORCEPS
K926538 · Thomasville Medical Assoc. · Feb 1994
THOMAS MEDICAL BIOPSY FORCEPS
K930036 · Thomasville Medical Assoc. · Feb 1994
ROTO FIT BIOPSY FORCEPS
K891043 · Zinnanti Surgical Instruments, Inc. · Mar 1989
ZSI BIOPSY FORCEPS
K891027 · Zinnanti Surgical Instruments, Inc. · Mar 1989