One Incision Bi-Polar Electro. Forceps
FDA 510(k) K781089 · Kli
510(k) numberK781089
Submission
- Device name
- One Incision Bi-Polar Electro. Forceps
- Applicant
- Kli
Mchenry, IL, US - Received
- June 29, 1978
- Decision date
- July 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIN – Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4150
- Specialty
- Obstetrics/Gynecology
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| K990147 | Bipolar Forceps, Kleppinger Insert, Model #'S 8393.741,8393.771,8394.741,8394.771HIN · Traditional | Richard Wolf Medical Instruments Corp. | 04/16/1999SE |
| K971565 | Bicoag Coagulating ForcepsHIN · Traditional | Everest Medical Corp. | 03/12/1998SE |
| K926517 | Elmed LBC 50-PHIN · Traditional | Elmed, Inc. | 11/15/1994SE |
More from Elmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K800822 | CO2 Cystoscopy/Urethroscopy ConsoleFAP · Traditional | 06/17/1980SE |
| K800913 | Gynecological Cysto/UrethroscopeFGC · Traditional | 05/14/1980SE |
| K781913 | Insuffalator LaparaoscopicHIF · Traditional | 12/04/1978SE |
| K781109 | Forceps, ElectrosurgicalHIN · Traditional | 09/14/1978SE |
| K780955 | Scissors, Hook, ElectrosurgicalKNF · Traditional | 06/22/1978SE |
| K780954 | Scissors, Hook, ElectrosurgicalKNF · Traditional | 06/22/1978SE |
| K772297 | Insufflator, Model G100 & 200HIF · Traditional | 01/05/1978SE |
| K772242 | Laparoscopy Console Model ViiiHET · Traditional | 12/20/1977SE |
| K772220 | Probe, Coagulation AccessoryKNF · Traditional | 12/13/1977SE |
| K772185 | Laparoscope W/Removable OpticsHET · Traditional | 11/30/1977SE |
Questions and answers
When was One Incision Bi-Polar Electro. Forceps cleared by the FDA?
One Incision Bi-Polar Electro. Forceps (K781089) received a 510(k) decision of Substantially Equivalent on July 17, 1978, 18 days after the submission was received.
What is the product code of K781089?
The FDA product code is HIN – Coagulator-Cutter, Endoscopic, Bipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4150.