Cleared Traditional

K935070 - GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS

K935070 is an FDA 510(k) clearance for GRASPING FORCEPS, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K935070 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
92d
Days
Class 1
Risk

K935070 is an FDA 510(k) clearance for the GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K935070

510(k) Number K935070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1993
Decision Date January 25, 1994
Days to Decision 92 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 131d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

FCL Device Classification - Class 1, General Controls

Product Code FCL Forceps, Biopsy, Non-electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
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 - FCL Forceps, Biopsy, Non-electric

All 38
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K935070.
GIP/MEDI-GLOBE BIOPSY FORCEPS
K941359 · Medi-Globe Corp. · Jul 1994
DAWN DISPOSABLE BIOPSY FORCEPS
K933135 · Dawn Medical · Mar 1994
SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS
K931957 · Symbiosis Corp. · Feb 1994
ACCU-PATH
K935250 · Cox Medical Ent., Inc. · Jan 1994
FORCEPS, BIOPSY, GASTROINTESTINAL
K934186 · Primed Instruments, Inc. · Dec 1993
BIOPSY FORCEPS
K925392 · Endo-Therapeutics, Inc. · Nov 1993
K935070 · GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
Download PDF FDA Summary KARL STORZ Endoscopy-…