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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 Apr 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 11 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 16, 1990
Date Received
Jan 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
510(k)

Other clearances by Bionix Development Corp.

  • K153270 — TruGuard Custom Tongue and Jaw Positioner (Mar 8, 2016)
  • K123411 — LITTLE ANGELS SWADDLING BLANKET (Mar 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 (Apr 9, 2010)
  • K050701 — THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 (Apr 1, 2005)
  • K040773 — PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM (Apr 9, 2004)
  • K030051 — VERSABOARD, MODEL 7040 (Apr 4, 2003)
  • K933614 — PITUITARY BOARD (Oct 7, 1993)
  • K933613 — 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER (Oct 7, 1993)

Other clearances for product code HFX

  • K251687 — Konig Bell Circumcision Clamp (Feb 25, 2026)
  • K221356 — Wee Bell (Feb 2, 2023)
  • K212911 — Konig Mogen Clamp (Nov 18, 2022)
  • K151095 — Circumplast Circumcision Device (Sep 18, 2015)
  • K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP (Apr 20, 2015)
  • K131373 — SHANGRING (Jun 25, 2013)
  • K121789 — SHANGRING (Aug 3, 2012)
  • K103695 — PREPEX SYSTEM (Jan 10, 2012)
  • K100916 — MEDICON MOGEN CLAMP (Dec 6, 2010)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (Sep 20, 2007)

FDA data resources