Cleared Traditional

SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA (K910985) - FDA 510(k) Clearance

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

K910985 · Precision Laser Products, Inc. · General & Plastic Surgery device
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Jul 1991
Decision
121d
Days
Class 2
Risk

K910985 is an FDA 510(k) clearance for the SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Precision Laser Products, Inc. (Sellersville, US). The FDA issued a Cleared decision on July 5, 1991 after a review of 121 days - within the typical 510(k) review window.

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: 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 Precision Laser Products, Inc. devices

Submission Details

510(k) Number K910985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date July 05, 1991
Days to Decision 121 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K910985.
ENDOSCOPE SUTURE & CARRIER
K912973 · United States Surgical, A Division of Tyco Healthc · Sep 1991
AUTO SUTURE ENDOSCOPIC FASCIA STAPLER
K912097 · United States Surgical, A Division of Tyco Healthc · Sep 1991
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION
K911105 · United States Surgical, A Division of Tyco Healthc · Aug 1991
STERILE DISPOSABLE TROCAR-SLEEVE DEVICES
K862611 · United States Surgical, A Division of Tyco Healthc · Jul 1986
TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM
K770711 · Richard Wolf Medical Instruments Corp. · Apr 1977
TROCAR SLEEVE SYSTEM 4MM TO 3.4MM
K770712 · Richard Wolf Medical Instruments Corp. · Apr 1977