510(k) K931935
- Device
- ENDPOINT 500 PERACETIC ACID TEST INDICATORS
- Applicant
- MINNTECH CORP.
- 510(k) number
- K931935
- Product code
- JOS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-07
- Date received
- 1993-04-19
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK ALDANA
- Address
- 14605 28th Ave. N. Minneapolis MN US 55447 55447
FDA Registration Numbers#
- 1833387
- 3042191618
- 3007412809
- 3021013267
- 3008559238
- 3021361802
- 3009219448
- 3010598169
- 9617111
- 1450962
- 3011494162
- 3016678045
- 3018047916
- 3000268902
- 2084725
- 3044819802
- 3014627756
- 3003418325
- 1450386
- 3015895045
- 3005030944
- 8030607
- 3024787345
- 3007743883
- 3010147274
- 3030733800
- 3013575574
- 3035856230
- 3042272797
- 3017498782
- 3012502601
- 8021899
- 3013187142
- 3031757047
- 3041276591
- 2515379
- 3030626857
- 3017113900
- 3017230778
- 1526531
- 8021896
- 3012421607
- 3014421917
- 3031841433
- 3029802606
- 2432141
- 3005698329
- 3036622014
- 2437780
- 3004215117
- 3013145340
- 2434982
- 3013298431
- 2013736
- 3043226252
- 3017524825
- 1416605
- 3045855232
- 3016075971
- 3014683120
- 3003950207
- 8030087
- 3011877754
- 2248608
- 2431166
- 9616872
- 2183301
- 1319130
- 3038138452
- 1051614
- 2132509
- 3008132392
- 3012494290
- 3007539307
- 3015392401
- 3036504234
- 2435946
- 3004634710
- 3017220525
- 1836161
Source Documents#
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 |
| K955636 | SENTRY DISPOSABLE DISPERSIVE ELECTRODE | Sentry Medical Products, Inc. | 1996-03-27 |
| K952290 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES | Mist, Inc. | 1995-06-23 |
Legacy Summary#
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FDA Review#
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