Emodren Exchangeable Plastic Bellows
FDA 510(k) K853295 · Parexel Intl. Corp.
510(k) numberK853295
Submission
- Device name
- Emodren Exchangeable Plastic Bellows
- Applicant
- Parexel Intl. Corp.
Cambridge, MA, US - Received
- August 6, 1985
- Decision date
- August 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4680
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972703 | Redyrob-Closed Wound Drainage SystemGCY · Traditional | B.Braun Medical, Inc. | 10/01/1997SE |
| K971036 | Odontit Autogenous Bone Collection DeviceGCY · Traditional | Interpore Intl. | 06/03/1997SE |
| K963839 | Cordis Suction Reservoir - Model Number: 910-500GCY · Traditional | Cordis Corp. | 12/12/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | Sil-Med Corp. | 03/11/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | Dlp, Inc. | 04/25/1995SE |
| K936223 | Pressure Irrigating SystemGCY · Traditional | Level 1 Technologies, Inc. | 05/12/1994SE |
| K930615 | Autovac Closed Wound Suction SystemGCY · Traditional | Boehringer Laboratories | 02/22/1994SE |
| K933319 | Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional | Birtcher Medical Systems, Inc. | 10/27/1993SE |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
More from Inman Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K900385 | Acta Metra/Acta Gnosis Firmware PackageDSI · Traditional | 07/09/1991SE |
| K904902 | Sma 26 TransducerITX · Traditional | 03/26/1991SE |
| K904901 | L11, L12 Linear and C11, C12 Convex Array TransducITX · Traditional | 03/26/1991SE |
| K884800 | Acta Genos ElectrocardiographDPS · Traditional | 06/22/1989SE |
| K862414 | Fuji CR Imaging PlateEAM · Traditional | 02/26/1987SE |
| K864519 | Philips Computed Radiography System (PCR)LLZ · Traditional | 02/13/1987SE |
| K862416 | Fti 100 Medical Thermal ImagerLMC · Traditional | 07/01/1986SE |
| K862415 | Type 633 Computed Radiography (CR) FilmIWZ · Traditional | 07/01/1986SE |
| K853296 | Emodren Guide Needle for Drainage Tube & EmodrenBYY · Traditional | 08/15/1985SE |
| K851322 | Personal C3 3-CHANNEL ElectrocardiographDPS · Traditional | 05/16/1985SE |
Questions and answers
When was Emodren Exchangeable Plastic Bellows cleared by the FDA?
Emodren Exchangeable Plastic Bellows (K853295) received a 510(k) decision of Substantially Equivalent on August 20, 1985, 14 days after the submission was received.
What is the product code of K853295?
The FDA product code is GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a Class I (low risk) device regulated under 21 CFR 878.4680.