Cleared Traditional

Pneumo Dissector Hook (K252957) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252957 · Ab Medica Sas · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
129d
Days
Class 2
Risk

K252957 is an FDA 510(k) clearance for the Pneumo Dissector Hook. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Ab Medica Sas (Centre-Val De Loire, FR). The FDA issued a Cleared decision on January 23, 2026 after a review of 129 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 Ab Medica Sas devices

Submission Details

510(k) Number K252957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2025
Decision Date January 23, 2026
Days to Decision 129 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
14d slower than avg
Panel avg: 115d · This submission: 129d
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 Consultant

Aztech Regulatory & Quality, LLC
Joseph Azary

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 437
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K252957.
1688 4K Camera System with Advanced Imaging Modality
K260185 · Stryker Endoscopy · Feb 2026
Saberscope™ Laparoscope (SAS-A-536L)
K260177 · Xenocor, Inc. · Feb 2026
Medical Shaver System (Morcellator) (YSB-IIIA)
K251923 · Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · Jan 2026
Connected OR Hub with Device and Voice Control
K254014 · Stryker Endoscopy · Jan 2026
KARL STORZ Cholangiography Set
K250927 · Karl Storz SE & CO. KG · Nov 2025
Nuvis® Wireless HD Camera System (Nuvis-2K)
K242606 · Integrated Endoscopy, Inc. · Nov 2025