S.C.M.T. Perforator
FDA 510(k) K871087 · Salt Creek Medical Technologies
510(k) numberK871087
Submission
- Device name
- S.C.M.T. Perforator
- Applicant
- Salt Creek Medical Technologies
Pinckney, MI, US - Received
- March 18, 1987
- Decision date
- March 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGE – Amniotome
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951148 | Obsti-HookHGE · Traditional | Onli | 06/09/1995SE |
| K926425 | Amniperf(Tm)HGE · Traditional | Raymart Development Co. | 03/07/1994SE |
| K910518 | Glove-N-Gel Amniotomy KitHGE · Traditional | Epcom Medical Systems, Inc. | 05/09/1991SESK |
| K850758 | Amniglove & AmnicotHGE · Traditional | Go Medical Industries Pty. , Ltd. | 04/15/1985SE |
| K834177 | H.R. Jakobi Surg. Instruments #4 30/31HGE · Traditional | Imm Enterprises , Ltd. | 12/27/1983SE |
More from Imm Enterprises , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K864683 | Neonatal Feeding KitKNT · Traditional | 04/17/1987SE |
| K871042 | Urine Meter, 250CCKNX · Traditional | 03/25/1987SE |
| K871075 | SCMT Umbilical ClampHFW · Traditional | 03/23/1987SE |
| K864296 | S.C.T. Multi Port, Injection SiteFPA · Traditional | 03/02/1987SE |
| K864682 | Salt Creek P.I. Tray · Traditional | 01/06/1987SE |
| K864692 | Extension SetsFPK · Traditional | 12/18/1986SE |
| K864693 | I.V. Start Kits · Traditional | 12/16/1986SE |
Questions and answers
When was S.C.M.T. Perforator cleared by the FDA?
S.C.M.T. Perforator (K871087) received a 510(k) decision of Substantially Equivalent on March 23, 1987, 5 days after the submission was received.
What is the product code of K871087?
The FDA product code is HGE – Amniotome, a Class I (low risk) device regulated under 21 CFR 884.4530.