Endoscopic Sclerotherapy Balloon
FDA 510(k) K821999 · Retech
510(k) numberK821999
Submission
- Device name
- Endoscopic Sclerotherapy Balloon
- Applicant
- Retech
Mchenry, IL, US - Received
- July 7, 1982
- Decision date
- August 27, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCP – Endoscope, Ac-Powered And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954614 | Eos Brand Disposable ProctoscopeGCP · Traditional | North Eos Industries, Inc. | 04/10/1996SE |
| K896505 | Porges Universal HandlesGCP · Traditional | Porges Corp. | 01/30/1990SE |
| K896008 | Model 6500 Mercury Arc Light SourceGCP · Traditional | Medical Dynamics, Inc. | 12/27/1989SE |
| K862424 | Steerable Catheter SystemGCP · Traditional | Endovations | 09/22/1986SE |
| K860103 | Mod. Endoport Single-Use Trocar and SleeveGCP · Traditional | Endotherapeutics | 02/12/1986SE |
| K843683 | Modular Fiberscope SystemGCP · Traditional | Reichert Scientific Instruments | 01/18/1985SE |
| K833859 | Tamponade Balloon CuffGCP · Traditional | American Endoscopy, Inc. | 01/03/1984SE |
| K801247 | CCD Endoscope and AttachmentsGCP · Traditional | Welch Allyn, Inc. | 07/28/1980SE |
| K790071 | Endoscope and AccessoriesGCP · Traditional | Olympus Corp. | 04/02/1979SE |
| K771920 | Fiber Optics ProctoscopeGCP · Traditional | Propper Mfg. Co., Inc. | 10/20/1977SE |
Questions and answers
When was Endoscopic Sclerotherapy Balloon cleared by the FDA?
Endoscopic Sclerotherapy Balloon (K821999) received a 510(k) decision of Substantially Equivalent on August 27, 1982, 51 days after the submission was received.
What is the product code of K821999?
The FDA product code is GCP – Endoscope, Ac-Powered And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.