ROUND SILICONE DRAIN
FDA 510(k) clearance K782028 · decided 1978-12-20
Clearance details
- K-number
- K782028
- Device name
- ROUND SILICONE DRAIN
- Applicant
- Davol, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-12-05
- Decision date
- 1978-12-20
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- GCY
- Device class
- 1
- Regulation number
- 878.4680
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REDYROB-CLOSED WOUND DRAINAGE SYSTEM (K972703) | B.Braun Medical, Inc. | 1997-10-01 |
| ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (K971036) | Interpore Intl. | 1997-06-03 |
| CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (K963839) | Cordis Corp. | 1996-12-12 |
| PENROSE DRAIN MODELS 6001 - 6007 (K960099) | Sil-Med Corp. | 1996-03-11 |
| MACRO SUCTION TUBE MODEL NO 10061 (K950754) | Dlp, Inc. | 1995-04-25 |
| PRESSURE IRRIGATING SYSTEM (K936223) | Level 1 Technologies, Inc. | 1994-05-12 |
| AUTOVAC CLOSED WOUND SUCTION SYSTEM (K930615) | Boehringer Laboratories | 1994-02-22 |
| BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM (K933319) | Birtcher Medical Systems, Inc. | 1993-10-27 |
| IMC 5.0MM IRRIGATION/ASPIRATION PROBE (K933305) | Inman Medical Corp. | 1993-10-05 |
| IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (K933306) | Inman Medical Corp. | 1993-10-05 |
| INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (K933170) | Inman Medical Corp. | 1993-09-16 |
| POOLE TIP SUCTION PROBE (K931950) | Mayaguez Medical Center | 1993-08-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Arista AH (P050038/S042) | Davol, Inc. | 2024-11-04 |
| Arista AH (P050038/S040) | Davol, Inc. | 2023-08-09 |
| FlexiTip XL-R Applicator (P050038/S041) | Davol, Inc. | 2023-05-24 |
| Arista AH Absorbable Hemostatic Particles device (P050038/S038) | Davol, Inc. | 2021-10-22 |
| Arista AH Absorbable Hemostatic Particles Device (P050038/S039) | Davol, Inc. | 2021-08-20 |
| Arista AH Absorbable Hemostatic Particles (P050038/S037) | Davol, Inc. | 2021-07-06 |
| Arista AH Absorbable Hemostatic (P050038/S036) | Davol, Inc. | 2020-09-25 |
| Arista AH Absorbable Hemostatic Particles (P050038/S035) | Davol, Inc. | 2020-04-29 |