Cleared Traditional

ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM. (K922423) - FDA 510(k) Clearance

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

K922423 · Access Surgical Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
181d
Days
Class 2
Risk

K922423 is an FDA 510(k) clearance for the ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM.. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Access Surgical Intl., Inc. (Bedminster, US). The FDA issued a Cleared decision on November 18, 1992 after a review of 181 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 Access Surgical Intl., Inc. devices

Submission Details

510(k) Number K922423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1992
Decision Date November 18, 1992
Days to Decision 181 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 570
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K922423.
ELECTROSURGIAL INSTRUMENTS
K932654 · Medline Industries, Inc. · Feb 1994
ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD
K934985 · KARL STORZ Endoscopy-America, Inc. · Feb 1994
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K922576 · Aesculap, Inc. · Jun 1993
EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
K900332 · 3M Company · Feb 1990
ELECTRODE TIP CLEANER
K874775 · C.R. Bard, Inc. · Feb 1988
RADIOTOM 804
K844428 · Siemens Medical Solutions USA, Inc. · Feb 1985