Cleared Traditional

K930773 - SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K930773 · Symbiosis Corp. · Obstetrics & Gynecology device
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Jul 1994
Decision
527d
Days
Class 1
Risk

K930773 is an FDA 510(k) clearance for the SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS. Classified as Forceps, Biopsy, Gynecological (product code HFB), Class I - General Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on July 28, 1994 after a review of 527 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 Symbiosis Corp. devices

Submission Details

510(k) Number K930773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1993
Decision Date July 28, 1994
Days to Decision 527 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
367d slower than avg
Panel avg: 160d · This submission: 527d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.