Product code GCL— Gastroenterology, Urology

5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD

Classification name: Esophagoscope, General & Plastic Surgery
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Total cleared: 4
First cleared: 1992-10-30
Most recent: 1995-05-30

FDA classification definition

“If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”
— U.S. Food and Drug Administration, device classification record for product code GCL under 21 CFR 876.1500, via openFDA

Market context for product code GCL

FDA has cleared 4 devices under product code GCL between 1992 and 1995, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19952 clearances
19941 clearance
19921 clearance

Top applicants under product code GCL

Pentax Precision Instrument Corp.2 clearances
Phx Technologies Corp.1 clearance
C.R. Bard, Inc.1 clearance

Recent clearances under product code GCL

K951197 — FE-24X, FIBER ESOPHAGOSCOPEPentax Precision Instrument Corp.·1995-05-30
K951198 — FE-34TH, FIBER ESOPHAGOSCOPEPentax Precision Instrument Corp.·1995-05-30
K934510 — 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREADPhx Technologies Corp.·1994-02-17
K922086 — BARD BIOPSY FORCEPSC.R. Bard, Inc.·1992-10-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.