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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Sac, LLC Dba Pinnacle Medical Surgical devices

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
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 883
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K101733.
WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
K121380 · Teleflexmedical, Inc. · May 2012
ENDOSCOPIC APPLICATOR
K120608 · Micromedics, Inc. · Mar 2012
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
K112456 · Teleflexmedical, Inc. · Oct 2011
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
K101077 · Intuitive Surgical, Inc. · Feb 2011
LTF-Y0009
K102379 · Olympus Medical Systems Corporation · Jan 2011
HYBRID TROCAR SYSTEM
K101937 · Aesculap, Inc. · Aug 2010