510(k) K955636
- Device
- SENTRY DISPOSABLE DISPERSIVE ELECTRODE
- Applicant
- SENTRY MEDICAL PRODUCTS, INC.
- 510(k) number
- K955636
- Product code
- JOS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-27
- Date received
- 1995-12-11
- Regulation
- 878.4400
- Classification name
- Electrode, Electrosurgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES IVERS
- Address
- 331 S. Eisenhower Ln. Lombard IL US 60148 60148
FDA Registration Numbers#
- 1721251
- 1018470
- 1222993
- 3013557681
- 2183744
- 3016678045
- 3006546082
- 3013247477
- 3007544634
- 3013188547
- 1058584
- 3012322232
- 1220477
- 2219920
- 9610614
- 3008361498
- 1320894
- 3014891416
- 1717344
- 9610773
- 3002808022
- 3007305485
- 3007421149
- 1219619
- 2434839
- 3004491689
- 1061927
- 3010707607
- 3026612481
- 3011050570
- 9610849
- 9610617
- 3009762450
- 3010202439
- 8040510
- 3018094310
- 3009241989
- 2020550
- 3004784537
- 1319660
- 3014342096
- 3007960282
- 3012494290
- 1319639
- 1721194
- 9680721
- 8010510
- 9681191
- 3013557562
- 3015136673
- 3043226252
- 1017294
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JOS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161600 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2016-09-06 |
| K050923 | LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR | Conmed Linvatec | 2005-05-18 |
| K012684 | REPROCESSED ELECTROSURGICAL ELECTRODE | Sterilmed, Inc. | 2002-01-18 |
| K011515 | MEDLINE GROUNDING PAD | Medline Industries, Inc. | 2001-07-13 |
| K003403 | ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 | Highland / Marietta, Inc. | 2001-05-07 |
| K000333 | STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD | Triad Surgical Technologies, Inc. | 2000-05-03 |
| K993885 | ULTRABLATOR ELECTRODE | Linvatec Corp. | 2000-02-10 |
| K991830 | CAPSULAR SHRINKAGE ELECTRODE | Linvatec Corp. | 1999-08-20 |
| K974735 | STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE | Aaron Medical Industries | 1998-06-24 |
| K973554 | VALLEY FORGE BIPOLAR BALL TIP ELECTRODE | Valley Forge Scientific Corp. | 1997-12-19 |
| K971187 | STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE | Aaron Medical Industries | 1997-05-05 |
| K962544 | MICRO DIAMOND-POINT DISSECTION NEEDLES | Dsp Worldwide | 1996-09-20 |
| K962313 | MODIFIED LEVEEN NEEDLE ELECTRODE | Radiotherapeutics Corp. | 1996-09-11 |
| K952290 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES | Mist, Inc. | 1995-06-23 |
| K952323 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES | Mist, Inc. | 1995-06-23 |
Legacy Summary#
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FDA Review#
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