Cleared Traditional

K910074 - LAPAROMED HOOK/SPATULA DEVICE

K910074 is an FDA 510(k) clearance for LAPAROMED HOOK/SPATULA DEVICE, manufactured by Laparomed Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K910074 · Laparomed Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
175d
Days
Class 2
Risk

K910074 is an FDA 510(k) clearance for the LAPAROMED HOOK/SPATULA DEVICE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Laparomed Corp. (Irvine, US). The FDA issued a Cleared decision on July 2, 1991 after a review of 175 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Laparomed Corp. devices

FDA 510(k) Submission Details - K910074

510(k) Number K910074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1991
Decision Date July 02, 1991
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1195
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K910074.
ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS
K912337 · Megadyne Medical Products, Inc. · Aug 1991
E-Z CLEAN LAPAROSCOPIC ELECTRODE
K913281 · Megadyne Medical Products, Inc. · Aug 1991
MODELS UES-10 & PSD-10
K911904 · Olympus Corp. · Jul 1991
LAPAROSCOPIC ELECTRODE WITH LAVAGE AND SUCTION
K911476 · United States Endoscopy Group, Inc. · Jul 1991
LAPAROSCOPIC ELECTRODE
K911491 · United States Endoscopy Group, Inc. · Jul 1991
COOK TISSUE MORCELLATOR
K910939 · Cook Urological, Inc. · Jun 1991