Cleared Traditional

K970712 - LAPARO-TENSER

K970712 is an FDA 510(k) clearance for LAPARO-TENSER, manufactured by L & T S.N.C. DI E. Lucini & C.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 510-day FDA review.

K970712 · L & T S.N.C. DI E. Lucini & C. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
510d
Days
Class 2
Risk

K970712 is an FDA 510(k) clearance for the LAPARO-TENSER. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by L & T S.N.C. DI E. Lucini & C. (Milano, IT). The FDA issued a Cleared decision on July 21, 1998 after a review of 510 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 L & T S.N.C. DI E. Lucini & C. devices

FDA 510(k) Submission Details - K970712

510(k) Number K970712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1997
Decision Date July 21, 1998
Days to Decision 510 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
350d slower than avg
Panel avg: 160d · This submission: 510d
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 217
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K970712.
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
K982428 · Innervision, Inc. · Oct 1998
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K982149 · Smith & Nephew, Inc. · Sep 1998
KSEA ENDO TIP SYSTEM
K981130 · KARL STORZ Endoscopy-America, Inc. · Aug 1998
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
K974763 · Deroyal Industries, Inc. · Jul 1998
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
K970968 · Guenter Bissinger Medizintechnik GmbH · May 1998
KSEA PLASTIC TROCARS
K980694 · KARL STORZ Endoscopy-America, Inc. · May 1998