Cleared Traditional

K101733 - REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES

K101733 is an FDA 510(k) clearance for REUSABLE, manufactured by Sac, LLC Dba Pinnacle Medical Surgical. The device is a Class 2 General Hospital device with product code GCJ cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K101733 · Sac, LLC Dba Pinnacle Medical Surgical · General Hospital
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Jun 2011
Decision
350d
Days
Class 2
Risk

K101733 is an FDA 510(k) clearance for the REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Sac, LLC Dba Pinnacle Medical Surgical (Orlando, US). The FDA issued a Cleared decision on June 6, 2011 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K101733

510(k) Number K101733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2010
Decision Date June 06, 2011
Days to Decision 350 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 129d · This submission: 350d
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 Hospital devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1429
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K101733.
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
K112456 · Teleflexmedical, Inc. · Oct 2011
THE ESPINER SAC OR E SAC
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VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
K112349 · Covidien, Formerly US Surgical A Divison of Tyco H · Sep 2011
UNIMAX SUCTION IRRIGATION SET
K103509 · Unimax Medical Systems, Inc. · May 2011
WEXLER ENDOSCOPE ACCESSORIES
K110121 · Microsurgical Laboratories,Inc.Dba Wexler Surgical · May 2011
UNIMAX SPECIMEN RETRIEVAL SYSTEM
K103510 · Unimax Medical Systems, Inc. · May 2011
K101733 · REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
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