Cleared Traditional

K051610 - HANS HERMANN LAPAROSCOPES AND ACCESSORIES

K051610 is an FDA 510(k) clearance for HANS HERMANN LAPAROSCOPES AND ACCESSORIES, manufactured by Hans Hermann GmbH. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K051610 · Hans Hermann GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
42d
Days
Class 2
Risk

K051610 is an FDA 510(k) clearance for the HANS HERMANN LAPAROSCOPES AND ACCESSORIES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Hans Hermann GmbH (Wurmlingen, DE). The FDA issued a Cleared decision on July 29, 2005 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K051610

510(k) Number K051610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2005
Decision Date July 29, 2005
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GCJ Device Classification - Class 2, Special Controls

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

Tuv America, Inc.
STEFAN PREISS

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 1431
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K051610.
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
K052740 · Conmed Integrated Systems (Cmis) · Oct 2005
F-400 SYSTEM
K051585 · Mauna Kea Technologies · Sep 2005
ENDOSCOPIC APPLICATOR
K051732 · Ethicon, Inc. · Aug 2005
ARMAND ENDOSCOPE HOLDER
K050051 · KLS-Martin L.P. · May 2005
NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000
K050650 · Cytyc Surgical Products · May 2005
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
K050829 · Conmed Integrated Systems (Cmis) · May 2005

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K051610 · HANS HERMANN LAPAROSCOPES AND ACCESSORIES
Download PDF FDA Summary Hans Hermann GmbH