Iop Adjustable Stirrup

FDA 510(k) K884558 · Mend Technologies, Inc.

Substantially Equivalent

510(k) numberK884558

Submission

Device name
Iop Adjustable Stirrup
Applicant
Mend Technologies, Inc.
Dallas, TX, US
Received
October 31, 1988
Decision date
November 17, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BWN – Table And Attachments, Operating-Room
Device class
Class I (low risk)
Regulation
21 CFR 878.4950
Specialty
General, Plastic Surgery

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K925005Isi Self-Supporting ArmBWN · Traditional Instrumentation Specialties, Inc.04/29/1993SE
K922288Holder, Pediatric PositionBWN · Traditional Yamashita and Hemsley Business Trust02/10/1993SE
K910783Shampaine Model 3800 or Muranaka Model OR-604MBWN · Traditional Smith & Nephew Equipment Group04/02/1991SE
K902865Baumer Surgical TableBWN · Traditional Sds Dental, Inc.09/10/1990SE
K875291Spinal Surgery FrameBWN · Traditional T. Korossurgical Instruments Corp.01/22/1988SE
K873272Endoscopy Table 1532 EndostarBWN · Traditional Stierlen-Maquet AG09/08/1987SE
K860177Allen Universal StirrupBWN · Traditional Edgewater Medical Equipment Systems02/11/1986SE
K852332Table Accessories, Operating RoomBWN · Traditional Scholten Surgical Instruments, Inc.07/02/1985SE

More from Scholten Surgical Instruments, Inc.

510(k)DeviceDecision
K924094Mend ApcJEA · Traditional 03/30/1993SE
K883867Cervical Biopsy InstrumentHEB · Traditional 11/29/1988SE

Questions and answers

When was Iop Adjustable Stirrup cleared by the FDA?

Iop Adjustable Stirrup (K884558) received a 510(k) decision of Substantially Equivalent on November 17, 1988, 17 days after the submission was received.

What is the product code of K884558?

The FDA product code is BWN – Table And Attachments, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4950.