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510(k) K113080

TUBALGATOR by Mectra Labs, Inc. — Product Code HIN

K113080 is an FDA 510(k) premarket notification submitted by Mectra Labs, Inc. for the device "TUBALGATOR". The FDA issued a decision of Substantially Equivalent on June 29, 2012. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. Mectra Labs, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2012
Date Received
October 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4150
Review Panel
OB
Submission Type

Other clearances by Mectra Labs, Inc.

  • K033880 — ELECTRO-LUBE (March 10, 2004)
  • K021247 — PNEUMOPERITONEUM INSUFFLATION NEEDLE (November 8, 2002)
  • K993604 — ENDOSCOPIC ANTI FOG DEVICE (March 3, 2000)
  • 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 HIN

  • K142525 — PK Lap Loop (November 21, 2014)
  • K130305 — LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE (July 24, 2013)
  • K122983 — KSEA BIPOLAR ELECTRODE (June 26, 2013)
  • K122605 — PKS BILL (December 5, 2012)
  • K111751 — VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP E (December 2, 2011)
  • K111059 — GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (September 1, 2011)
  • K990147 — BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.77 (April 16, 1999)
  • K971565 — BICOAG COAGULATING FORCEPS (March 12, 1998)
  • K926517 — ELMED LBC 50-P (November 15, 1994)
  • K943776 — COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (November 3, 1994)

FDA data resources