Product code KDD
- Device name
- Kit, Surgical Instrument, Disposable
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072814 | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES | Covidien | 2008-04-16 |
| K011514 | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE | Kencap , Ltd. | 2001-08-13 |
| 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 |
| K911606 | BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES | Baxter Healthcare Corp | 1991-07-09 |
| K910816 | IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE | Insight International, Inc. | 1991-04-17 |
| K910369 | INCISION AND DRAINAGE KIT | Megadyne Medical Products, Inc. | 1991-03-28 |
| K910366 | MEGA GENERAL PURPOSE INSTRUMENT KIT | Megadyne Medical Products, Inc. | 1991-03-28 |
| K902441 | DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) | Currie Medical Specialties, Inc. | 1990-08-23 |
| K880785 | SKILCRAFT | Pennsylvania Association For the Blind | 1988-03-11 |
| K874063 | ENTERON ABDOMINAL PARACENTESIS TRAY | Endovations | 1987-12-04 |
| K871458 | SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW | Fraass Survival Systems, Inc. | 1987-07-09 |
| K870373 | STERILE PROCEDURAL TRAYS | Dimed, Intl. | 1987-03-20 |
| K864969 | JMS HALO APPLICATION TRAY | Jerome Medical | 1987-02-18 |
| K853910 | SUTURE REMOVAL KIT | Scientific & Medical Care Co. | 1985-10-08 |
| K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET | Geneva Laboratories, Inc. | 1985-05-24 |
| K850325 | STERILE SUTURE REMOVAL KIT | Excel Health Care Products | 1985-02-26 |
| K842627 | C-SECTION TRAY | Deroyal Industries, Inc. | 1984-09-26 |
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| 10193489951936 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2024-07-29 |
| 08906039319729 | OSSEOUS Myringotomy Kit-Standard | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| 08906039319736 | OSSEOUS Myringotomy Kit-Pediatric | EON MEDITECH PRIVATE LIMITED | 2024-07-04 |
| 10192253065442 | Aero-Med | AERO-MED, LLC | 2024-03-11 |
| 00811870037979 | Manus Medical, LLC | Manus Medical, LLC | 2024-02-06 |
| 10193489447897 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-06-08 |
| 10080196813841 | Medline | MEDLINE INDUSTRIES, INC. | 2022-11-08 |
| 10192253061116 | Aero-Med | AERO-MED, LLC | 2022-04-15 |
| 10195327103804 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-02-13 |
| 10195327101954 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-02-13 |
| 10195327100148 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-02-13 |
| 10195327100131 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-02-13 |
| 10195327093655 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-02-13 |
| 10195327093563 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-02-06 |
| 10193489977356 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-09-05 |
| 10193489979237 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-09-05 |
| 10193489982589 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-09-05 |
| 10080196188680 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-05-11 |
| 10193489194197 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-23 |
| 10193489191585 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-20 |
| 08498840009796 | VYGON | Vygon Corporation | 2016-09-15 |
| 08498840009673 | VYGON | Vygon Corporation | 2016-09-15 |
| 08498840008393 | VYGON | Vygon Corporation | 2016-09-15 |
| 08498840005767 | VYGON | Vygon Corporation | 2016-09-02 |
| 08498840003947 | VYGON | Vygon Corporation | 2016-09-02 |
| 07613154643271 | NA | STRYKER CORPORATION | 2015-09-09 |
| 07613154643264 | NA | STRYKER CORPORATION | 2015-09-09 |