510(k) K011514
- Device
- INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
- Applicant
- KENCAP LTD.
- 510(k) number
- K011514
- Product code
- KDD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-13
- Date received
- 2001-05-17
- Regulation
- 878.4800
- Classification name
- Kit, Surgical Instrument, Disposable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTY DELIN
- Address
- 247 Margaret King Ave. Ringwood NJ US 07456 07456
FDA Registration Numbers#
- 9611024
- 1061124
- 1060680
- 3009888344
- 1032347
- 3010531069
- 3004638532
- 1064371
- 1043534
- 3010583458
- 3010380518
- 2024311
- 3010536692
- 3031180770
- 3005034064
- 9616872
- 1420054
- 3009189869
- 3009746061
- 3010760216
- 2433012
- 1643116
- 1423537
- 3008808049
- 3006673317
- 1055236
- 3034676720
- 1018470
- 3039169546
- 3007681502
- 3001084743
- 3010610950
- 3004941127
- 3042158827
- 3032747418
- 3011585752
- 1721504
- 3009513193
- 9617229
- 1054241
- 3016195240
- 3005515211
- 3033509898
- 3023464160
- 3004605321
- 3013466775
- 3011499367
- 3005675811
- 3005273623
- 3025603301
- 1211998
- 1125782
- 3006542380
- 3003139373
- 3003604053
- 3003528228
- 3010459874
- 3038220293
- 3045816907
- 3005669815
- 3007123908
- 3017461134
- 1048735
- 3011089435
- 3002807310
- 1417592
- 1824619
- 3008902714
- 1935627
- 3013980229
- 8043792
- 1649518
- 3016874083
- 1422634
- 1721676
- 3027807601
- 3025686427
- 3005595283
- 3005440795
- 3044571218
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KDD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072814 | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES | Covidien | 2008-04-16 |
| K971317 | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | National Healthcare Mfg. Corp. | 1997-05-08 |
| K960456 | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY | Denver Biomaterials, Inc. | 1996-04-01 |
| K936255 | CUSTOM CV PACK | Associated Medical | 1994-03-31 |
| K932219 | SUTURE SET OR LACERATION TRAYS (PACKS) | Associated Medical Products Co. | 1993-07-09 |
| K923176 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1993-06-17 |
| K925905 | KIT, SURGICAL INSTRUMENT, DISPOSABLE | Kay Medical Concepts | 1993-06-16 |
| K924958 | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY | Medical Insights, Inc. | 1993-06-07 |
| K925215 | STERILE SURGICAL INSTRUMENT TRAYS | American Healthcare Supply Co., Inc. | 1993-06-01 |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Dexide, Inc. | 1993-03-23 |
| K920989 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1992-10-19 |
| K920763 | LACERATTION TRAY | Sterile Concepts, Inc. | 1992-09-28 |
| K920516 | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB | Trinity Laboratories, Inc. | 1992-04-16 |
| K914244 | STERILE CUSTOM SURGICAL KITS | Ulti-Med Intl., Inc. | 1992-02-24 |
| K913049 | SLIP-PRUF-CLINGER | Macbrud Corp. Medical Div. | 1991-09-11 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases