O'Brien Goniometer
FDA 510(k) K926237 · Sgarlato Laboratories, Inc.
510(k) numberK926237
Submission
- Device name
- O'Brien Goniometer
- Applicant
- Sgarlato Laboratories, Inc.
San Jose, CA, US - Received
- December 11, 1992
- Decision date
- August 2, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KQW – Goniometer, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1520
- Specialty
- Orthopedic
Other 510(k)s with product code KQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K901744 | Dobbhoff(R) Retrieval ForcepsKQW · Traditional | Biosearch Medical Products, Inc. | 07/03/1990SE |
| K870767 | The (Crom) TesterKQW · Traditional | Twin City Surgical, Inc. | 03/17/1987SE |
| K850082 | Hand Held GoniometerKQW · Traditional | Chattanooga Group, Inc. | 04/04/1985SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K812778 | The Telos EquipmentKQW · Traditional | The Telos Co. | 12/08/1981SE |
| K810441 | Universal GonimeterKQW · Traditional | Fred Sammons, Inc. | 02/27/1981SE |
| K801718 | BK-7513 Stainless Steel GoniometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801717 | BK-7511 Brass GoniometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801716 | BK-7505 Radiopaque Goniometer, 8KQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801715 | BK-7497 Bulb DynamometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043204 | Sgarlato Labs Painfree Pump and Pain Control Infusion PumpFRN · Traditional | 03/30/2005SE |
| K990101 | Pain Control Infusion PumpFRN · Traditional | 03/19/1999SE |
| K982931 | Threaded Fixation PinJDW · Traditional | 10/21/1998SE |
| K926262 | First MPJ Continuous Passive Motion DeviceBXB · Traditional | 01/26/1994SE |
| K922292 | Lundeen Subtalar Peg ImplantMJW · Traditional | 10/23/1992SE |
| K905795 | Sgarlato Flexible Hinge Toe ImplantKWH · Traditional | 05/29/1991SE |
| K884739 | Sgarlato Lesser Toe ImplantKWH · Traditional | 05/18/1989SE |
Questions and answers
When was O'Brien Goniometer cleared by the FDA?
O'Brien Goniometer (K926237) received a 510(k) decision of Substantially Equivalent on August 2, 1993, 234 days after the submission was received.
What is the product code of K926237?
The FDA product code is KQW – Goniometer, Nonpowered, a Class I (low risk) device regulated under 21 CFR 888.1520.