Gillette Sabre Syringe
FDA 510(k) K833655 · Intermedics, Inc.
510(k) numberK833655
Submission
- Device name
- Gillette Sabre Syringe
- Applicant
- Intermedics, Inc.
Walker, MI, US - Received
- October 20, 1983
- Decision date
- December 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | 12/16/1996PT |
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| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | 08/21/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | 02/27/1996ST |
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | 03/15/1995SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | 01/22/1993SESP |
| K920530 | Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional | 03/17/1992SE |
Questions and answers
When was Gillette Sabre Syringe cleared by the FDA?
Gillette Sabre Syringe (K833655) received a 510(k) decision of Substantially Equivalent on December 29, 1983, 70 days after the submission was received.
What is the product code of K833655?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.