Op-Con Surgical Instrument #9
FDA 510(k) K834169 · Imm Enterprises , Ltd.
510(k) numberK834169
Submission
- Device name
- Op-Con Surgical Instrument #9
- Applicant
- Imm Enterprises , Ltd.
Walker, MI, US - Received
- November 21, 1983
- Decision date
- January 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWB – Forceps, Tube Introduction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5780
- Specialty
- Anesthesiology
Other 510(k)s with product code BWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884584 | Tongue Seizing Forceps with & Without Rubber PadsBWB · Traditional | Eastmed Enterprises, Inc. | 11/14/1988SE |
| K880319 | Magill ForcepsBWB · Traditional | Eastmed Enterprises, Inc. | 03/21/1988SE |
| K880318 | Rovenstein ForcepsBWB · Traditional | Eastmed Enterprises, Inc. | 03/21/1988SE |
| K840313 | Cat. 9 Anesthesiology Respiratory DevBWB · Traditional | Imm Enterprises , Ltd. | 02/04/1984SE |
| K820451 | Introducer for Endotracheal TubeBWB · Traditional | Imed Corp. | 03/26/1982SE |
More from Imed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K841387 | Weston Rectal SnareKOA · Traditional | 05/09/1984SE |
| K841386 | Kollmann Urethral DilatorKOE · Traditional | 05/09/1984SE |
| K840311 | Cat. 7-EAR, Nose & Throat DevicesKCP · Traditional | 05/09/1984SE |
| K840304 | Category 17-MICROBIOLOGY DevicesHTD · Traditional | 05/01/1984SE |
| K840318 | Cat. 14-CLINICAL Toxiology DevicesHTD · Traditional | 04/23/1984SE |
| K840305 | Category 1 Circulatory System DeviceDWS · Traditional | 04/23/1984SE |
| K840312 | Cat. 8 Dental DevicesEMG · Traditional | 04/05/1984SE |
| K834171 | Op-Con Surg. Instrument #3KOA · Traditional | 04/04/1984SE |
| K834192 | Jakobi Surg. Instruments #3 21/22/24KOA · Traditional | 03/22/1984SE |
| K834191 | Jakobi Surgical Instruments #3 17/18/19KOA · Traditional | 03/22/1984SE |
Questions and answers
When was Op-Con Surgical Instrument #9 cleared by the FDA?
Op-Con Surgical Instrument #9 (K834169) received a 510(k) decision of Substantially Equivalent on January 17, 1984, 57 days after the submission was received.
What is the product code of K834169?
The FDA product code is BWB – Forceps, Tube Introduction, a Class I (low risk) device regulated under 21 CFR 868.5780.