Titan Insufflation Needle

FDA 510(k) K950243 · Endolap, Inc.

Substantially Equivalent

510(k) numberK950243

Submission

Device name
Titan Insufflation Needle
Applicant
Endolap, Inc.
Orlando, FL, US
Received
January 20, 1995
Decision date
April 6, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GCJ – Laparoscope, General & Plastic Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

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).

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More from TroCare, LLC

510(k)DeviceDecision
K974516Endolap Resectoscope Cutting Loop ElectrodeFAS · Traditional 12/22/1997SE
K974515Endolap Resectoscope Roller ElectrodeFAS · Traditional 12/22/1997SE
K950219Endolap Insufflator Tubing SetHIF · Traditional 03/23/1995SE
K933492Esys SystemHET · Traditional 03/25/1994SE

Questions and answers

When was Titan Insufflation Needle cleared by the FDA?

Titan Insufflation Needle (K950243) received a 510(k) decision of Substantially Equivalent on April 6, 1995, 76 days after the submission was received.

What is the product code of K950243?

The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.