Cleared Traditional

K952508 - FLOW-THERME, WISAP #7642

K952508 is an FDA 510(k) clearance for FLOW-THERME, manufactured by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K952508 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
86d
Days
Class 2
Risk

K952508 is an FDA 510(k) clearance for the FLOW-THERME, WISAP #7642. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (Sauerlach, DE). The FDA issued a Cleared decision on August 25, 1995 after a review of 86 days - a notably fast clearance cycle.

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: 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 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh devices

FDA 510(k) Submission Details - K952508

510(k) Number K952508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1995
Decision Date August 25, 1995
Days to Decision 86 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
74d faster than avg
Panel avg: 160d · This submission: 86d
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 218
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K952508.
PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
K940265 · Cook Urological, Inc. · Sep 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200 · Olympus America, Inc. · Sep 1995
KARL STORZ SUCTION CATHETERS
K951250 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
STRYKER OPERATING LAPAROSCOPE
K943100 · Stryker Endoscopy · Aug 1995
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE
K951394 · KARL STORZ Endoscopy-America, Inc. · Jul 1995
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K950962 · KARL STORZ Endoscopy-America, Inc. · Jul 1995