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510(k) K900370

ONE/CIRC (CIRCUMCISION CLAMP) by Bionix Development Corp. — Product Code HFX

K900370 is an FDA 510(k) premarket notification submitted by Bionix Development Corp. for the device "ONE/CIRC (CIRCUMCISION CLAMP)". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Bionix Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
January 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Circumcision
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Bionix Development Corp.

  • K153270 — TruGuard Custom Tongue and Jaw Positioner (March 8, 2016)
  • K123411 — LITTLE ANGELS SWADDLING BLANKET (March 7, 2013)
  • K120335 — EMBRACE THERMOPLASTIC (May 3, 2012)
  • K100691 — OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 (May 11, 2010)
  • K100264 — T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 (April 9, 2010)
  • K050701 — THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 (April 1, 2005)
  • K040773 — PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM (April 9, 2004)
  • K030051 — VERSABOARD, MODEL 7040 (April 4, 2003)
  • K933614 — PITUITARY BOARD (October 7, 1993)
  • K933613 — 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER (October 7, 1993)

Other clearances for product code HFX

  • K251687 — Konig Bell Circumcision Clamp (February 25, 2026)
  • K221356 — Wee Bell (February 2, 2023)
  • K212911 — Konig Mogen Clamp (November 18, 2022)
  • K151095 — Circumplast Circumcision Device (September 18, 2015)
  • K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP (April 20, 2015)
  • K131373 — SHANGRING (June 25, 2013)
  • K121789 — SHANGRING (August 3, 2012)
  • K103695 — PREPEX SYSTEM (January 10, 2012)
  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)

FDA data resources