Morgan Suture-Drill
FDA 510(k) K853376 · Bowen & Company, Inc.
510(k) numberK853376
Submission
- Device name
- Morgan Suture-Drill
- Applicant
- Bowen & Company, Inc.
Rockville, MD, US - Received
- August 12, 1985
- Decision date
- November 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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|---|---|---|
| K896898 | Bowen Electrode Skin Prepatory CleanserLKB · Traditional | 04/04/1990SE |
| K896538 | Disposable 45 Degree ShaverHRX · Traditional | 12/06/1989SE |
| K873766 | Sternal Power AwlKIJ · Traditional | 11/14/1988SE |
| K872098 | Cremeen Alveolar Bone CaliperEIL · Traditional | 07/31/1987SE |
| K871325 | Bowen Reuseable/Disposable ElectrodeDRX · Traditional | 06/08/1987SE |
| K870882 | 45 Degree ShaverHTZ · Traditional | 03/23/1987SE |
| K870881 | Loose Body GraspersHTD · Traditional | 03/23/1987SE |
| K863150 | Bowen CannulaGEA · Traditional | 09/05/1986SE |
| K863149 | Bowen ProbeHXB · Traditional | 09/05/1986SE |
| K863148 | Bowen Knot PasserHXI · Traditional | 09/05/1986SE |
Questions and answers
When was Morgan Suture-Drill cleared by the FDA?
Morgan Suture-Drill (K853376) received a 510(k) decision of Substantially Equivalent on November 13, 1985, 93 days after the submission was received.
What is the product code of K853376?
The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.