Cleared Traditional

K962005 - EXTRAHAND BALLOON RETRACTOR

K962005 is an FDA 510(k) clearance for EXTRAHAND BALLOON RETRACTOR, manufactured by Origin Medsystems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K962005 · Origin Medsystems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
82d
Days
Class 2
Risk

K962005 is an FDA 510(k) clearance for the EXTRAHAND BALLOON RETRACTOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Origin Medsystems, Inc. (Menlo Park, US). The FDA issued a Cleared decision on August 12, 1996 after a review of 82 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.

View all Origin Medsystems, Inc. devices

FDA 510(k) Submission Details - K962005

510(k) Number K962005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1996
Decision Date August 12, 1996
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - GCJ Laparoscope, General & Plastic Surgery

All 723
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K962005.
ETHICON ENDOSUTURE SYSTEM
K963329 · Ethicon, Inc. · Oct 1996
AIRLIFT BALLOON RETRACTON SYSTEM
K962104 · Origin Medsystems, Inc. · Sep 1996
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
K960903 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
SPECIMEN RETRIEVAL BAG
K962395 · Applied Medical Resources · Jul 1996
5MM ENDOSCOPE
K960637 · Origin Medsystems, Inc. · Jun 1996
GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005
K960562 · Conmedcorp · Apr 1996