Cleared Traditional

K970968 - BISSINGER DETACHABLE BIPOLAR COAGULATIO...

K970968 is an FDA 510(k) clearance for BISSINGER DETACHABLE BIPOLAR COAGULATIO..., manufactured by Guenter Bissinger Medizintechnik GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K970968 · Guenter Bissinger Medizintechnik GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
430d
Days
Class 2
Risk

K970968 is an FDA 510(k) clearance for the BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Guenter Bissinger Medizintechnik GmbH (Teningen, DE). The FDA issued a Cleared decision on May 21, 1998 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 Guenter Bissinger Medizintechnik GmbH devices

FDA 510(k) Submission Details - K970968

510(k) Number K970968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1997
Decision Date May 21, 1998
Days to Decision 430 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
270d slower than avg
Panel avg: 160d · This submission: 430d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 172
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K970968.
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K980694 · KARL STORZ Endoscopy-America, Inc. · May 1998
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K972647 · Cook Urological, Inc. · Apr 1998
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K972488 · Karl Storz Endoscopy · Jan 1998