510(k) K821999
- Device
- ENDOSCOPIC SCLEROTHERAPY BALLOON
- Applicant
- RETECH
- 510(k) number
- K821999
- Product code
- GCP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-27
- Date received
- 1982-07-07
- Regulation
- 876.1500
- Classification name
- Endoscope, Ac-powered And Accessories
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009217531
- 3007388124
- 3004784537
- 9610773
- 8010487
- 3011986317
- 3013247477
- 8043235
- 1000343527
- 3011416394
- 3012460907
- 3007960282
- 3006680097
- 9614969
- 3013031133
- 8010257
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954614 | EOS BRAND DISPOSABLE PROCTOSCOPE | North Eos Industries, Inc. | 1996-04-10 |
| K896505 | PORGES UNIVERSAL HANDLES | Porges Corp. | 1990-01-30 |
| K896008 | MODEL 6500 MERCURY ARC LIGHT SOURCE | Medical Dynamics, Inc. | 1989-12-27 |
| K862424 | STEERABLE CATHETER SYSTEM | Endovations | 1986-09-22 |
| K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | Endotherapeutics | 1986-02-12 |
| K843683 | MODULAR FIBERSCOPE SYSTEM | Reichert Scientific Instruments | 1985-01-18 |
| K833859 | TAMPONADE BALLOON CUFF | American Endoscopy, Inc. | 1984-01-03 |
| K801247 | CCD ENDOSCOPE AND ATTACHMENTS | Welch Allyn, Inc. | 1980-07-28 |
| K790071 | ENDOSCOPE AND ACCESSORIES | Olympus Corp. | 1979-04-02 |
| K771918 | FIBEO OPTICS ILLUM. SYSTEM | Propper Mfg. Co., Inc. | 1977-10-20 |
| K771919 | FIBER OPTICS SIGMOIDOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 |
| K771920 | FIBER OPTICS PROCTOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 |
Legacy Summary#
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FDA Review#
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