Cleared Traditional

K933767 - FORCEPS

K933767 is an FDA 510(k) clearance for FORCEPS, manufactured by Mahe-Medizintechnik. The device is a Class 1 Obstetrics & Gynecology device with product code HFB cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K933767 · Mahe-Medizintechnik · Obstetrics & Gynecology device
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May 1994
Decision
301d
Days
Class 1
Risk

K933767 is an FDA 510(k) clearance for the FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY. Classified as Forceps, Biopsy, Gynecological (product code HFB), Class I - General Controls.

Submitted by Mahe-Medizintechnik (Nashville, US). The FDA issued a Cleared decision on May 26, 1994 after a review of 301 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Mahe-Medizintechnik devices

FDA 510(k) Submission Details - K933767

510(k) Number K933767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date May 26, 1994
Days to Decision 301 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 160d · This submission: 301d
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 9
Devices cleared under the same product code (HFB) and FDA review panel - the closest regulatory comparables to K933767.
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