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510(k) K993604

ENDOSCOPIC ANTI FOG DEVICE by Mectra Labs, Inc. — Product Code OCT

K993604 is an FDA 510(k) premarket notification submitted by Mectra Labs, Inc. for the device "ENDOSCOPIC ANTI FOG DEVICE". The FDA issued a decision of Substantially Equivalent on March 3, 2000. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500. Mectra Labs, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2000
Date Received
October 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Other clearances by Mectra Labs, Inc.

  • K113080 — TUBALGATOR (June 29, 2012)
  • K033880 — ELECTRO-LUBE (March 10, 2004)
  • K021247 — PNEUMOPERITONEUM INSUFFLATION NEEDLE (November 8, 2002)
  • K955352 — SUCTION CAUTERY PROBE (April 5, 1996)
  • K934547 — MECTRA TROCAR (February 18, 1994)
  • K935382 — GRASPERS (February 15, 1994)
  • K925691 — INSUFFLATION TUBING (September 23, 1993)
  • K920959 — INSUFFLATOR, LAPAROSCOPIC (July 13, 1992)

Other clearances for product code OCT

  • K251068 — KnoxFog Anti-fogging Device (August 27, 2025)
  • K231822 — GOLFF Sterile Anti-Fog Solution (February 26, 2024)
  • K221293 — E-Brik Visualization Assistant (July 7, 2022)
  • K190864 — Konix Anti-Fog Solution (August 27, 2020)
  • K181887 — AMD Anti-Fog Solution (January 22, 2019)
  • K163257 — VitreOx Anti-fog Solution (May 24, 2017)
  • K152948 — Medline Anti-Fog Solution (February 4, 2016)
  • K120821 — LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (May 11, 2012)
  • K111622 — UNIMAX ANTI-FOG SOLUTION (September 9, 2011)
  • K102452 — DEFOGGING AND CLEANING SOLUTION- FLO-X (December 23, 2010)

FDA data resources