Cleared Traditional

K922526 - DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL D...

K922526 is the FDA 510(k) clearance for DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL D... by Davol, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K922526 · Davol, Inc. · General & Plastic Surgery device
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Sep 1992
Decision
97d
Days
Class 2
Risk

K922526 is an FDA 510(k) clearance for the DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Davol, Inc. devices

Submission Details

510(k) Number K922526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1992
Decision Date September 02, 1992
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCJ Laparoscope, General & Plastic Surgery

All 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K922526.
ORIGIN FLEXIBLE PORT
K922751 · Origin Medsystems, Inc. · Nov 1992
ENDO-GARD ELECTROSURGICAL TROCAR
K915790 · Conmedcorp · Oct 1992
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR
K920068 · United States Surgical, A Division of Tyco Healthc · Sep 1992
HOOK SURGICAL INSTRUMENT
K920599 · Origin Medsystems, Inc. · Jul 1992
ENDOBAG, MODIFICATION
K921709 · Dexide, Inc. · Jul 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
K914752 · United States Surgical, A Division of Tyco Healthc · Jun 1992