Ser-Tex
FDA 510(k) K800834 · V.S.S.I., Inc.
510(k) numberK800834
Submission
- Device name
- Ser-Tex
- Applicant
- V.S.S.I., Inc.
Mchenry, IL, US - Received
- April 14, 1980
- Decision date
- June 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOH – Instrument, Manual, General Obstetric-Gynecologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KOH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000212 | Ksea Chardonnes Morcellation KnifeKOH · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/21/2000SE |
| K921732 | Minor Lap SetKOH · Traditional | Medikmark, Inc. | 06/15/1994SE |
| K921730 | C-Section PackKOH · Traditional | Medikmark, Inc. | 06/15/1994SE |
| K892693 | Vaginal Specula: Cusco, Guttman, InfantKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 05/11/1989SE |
| K891351 | Newport Lateral Vaginal RetractorKOH · Traditional | Simpson/Basye, Inc. | 05/11/1989SE |
| K891035 | Needle ExtensionsKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 03/22/1989SE |
| K891049 | Zeppelin ScissorsKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 03/17/1989SE |
| K863610 | The Ob-Gyn Concepts Vaginal AspiratorKOH · Traditional | Ob/Gyn Concepts, Ltd. | 01/07/1987SE |
| K840308 | Cat. 4-OBSTETRICS Gynecology Dev'sKOH · Traditional | Imm Enterprises , Ltd. | 03/05/1984SE |
| K823792 | Quartz Retractor/ProbeKOH · Traditional | American V. Mueller | 01/18/1983SE |
Questions and answers
When was Ser-Tex cleared by the FDA?
Ser-Tex (K800834) received a 510(k) decision of Substantially Equivalent on June 30, 1980, 77 days after the submission was received.
What is the product code of K800834?
The FDA product code is KOH – Instrument, Manual, General Obstetric-Gynecologic, a Class I (low risk) device regulated under 21 CFR 884.4520.