Product code BTX— General, Plastic Surgery

FDA has cleared 13 devices under product code BTX between 1977 and 1994, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19941 clearance
• 19901 clearance
• 19883 clearances
• 19871 clearance
• 19832 clearances
• 19821 clearance
• 19811 clearance
• 19791 clearance
• 19781 clearance
• 19771 clearance

• Edgewater Medical Systems, Inc.2 clearances
• Sentry Medical Products, Inc.1 clearance
• Sage Products, Inc.1 clearance
• Rick Robbin & Frederick Auerbach1 clearance
• Precept, Inc.1 clearance
• Medical Innovations Corp.1 clearance
• Karlin Technology, Inc.1 clearance
• Infection Control Products, Inc.1 clearance
• Harvey A. Turner, M.D.1 clearance
• Fibre Formations, Inc.1 clearance

• K935098 — BABY BOARDSentry Medical Products, Inc.·1994-02-15
• K900175 — 4/1 ARMBOARDInfection Control Products, Inc.·1990-01-24
• K884838 — ALLEN PRONE ARMBOARDEdgewater Medical Systems, Inc.·1988-12-15
• K882524 — UNIVERSALLY ADJUSTABLE ARMBOARDKarlin Technology, Inc.·1988-07-08
• K881292 — ALLEN LATERAL ARMBOARDEdgewater Medical Systems, Inc.·1988-04-07
• K864670 — BOARD, ARM (WITH COVER)Anago, Inc.·1987-01-12
• K833664 — ARMBOARD AND THE BOARDRick Robbin & Frederick Auerbach·1983-12-27
• K830018 — SAFE-T ARM BOARDHarvey A. Turner, M.D.·1983-01-26
• K823412 — ARM BOARD W/I.V COVERINGSage Products, Inc.·1982-12-15
• K811419 — SPRIO-LOOPDatamed, Inc.·1981-06-12
• K792147 — ARM SHIELD FOR ANESTHESIAMedical Innovations Corp.·1979-12-06
• K781233 — IV ARMBOARDSFibre Formations, Inc.·1978-08-14
• K770391 — COVER, ARMBOARD, DISPOSABLEPrecept, Inc.·1977-03-07