Cleared Traditional

K912129 - DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE

K912129 is an FDA 510(k) clearance for DOBBHOFF BIPOLAR HEMOSTATIC PROBE, manufactured by Biosearch Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K912129 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
85d
Days
Class 2
Risk

K912129 is an FDA 510(k) clearance for the DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K912129

510(k) Number K912129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date August 07, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 152
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K912129.
DOBBHOFF BIPOLAR ADAPTER
K921029 · Biosearch Medical Products, Inc. · May 1992
MONOPOLAR COAGULATING POLYPECTOMY SNARE
K920089 · Everest Medical Corp. · Mar 1992
BIPOLAR ENDOSTASIS PROBE, BEST (TM)
K915408 · Medical Devices, Inc. · Mar 1992
MONOPOLAR POLLYPECTOMY SNARE
K911700 · Everest Medical Corp. · Jul 1991
BIPROBE(TM)
K912601 · C.R. Bard, Inc. · Jun 1991
RESECTOSCOPE LOOPS
K903323 · Olympus Corp. · Oct 1990