Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008595179

FEI Number

3008595179

Entity Name

SAC LLC

City/State/Country

Sanford, FL, US

Establishment Address

2526 Old Lake Mary Rd., Sanford, FL 32773, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

SAC LLC dba Pinnacle Medical Surgical / Orange Surgical Inst (Owner Number: 10033801)

Owner / Operator Contact Address

2526 Old Lake Mary Road, Sanford, FL 32773, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101733

PMA Number

N/A

All Registered Proprietary Names

Reusable Disposable Laparoscopic Instrument and Surgical Device and Accessories Reusable Disposable Laparoscopic Instrument and Surgical Device and Accessories Reusable Disposable Laparoscopic Instrument and Surgical Device and Accessories Reusable Disposable Laparoscopic Instrument and Surgical Device and Accessories Reusable Disposable Laparoscopic Instrument and Surgical Device and Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-09-12
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2023-09-12
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2023-09-12
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2023-09-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-06-20
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2022-06-20
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2022-06-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-06-20
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2022-06-20

Official Correspondent

Michael Athey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SAC LLC dba Pinnacle Medical Surgical / Orange Surgical Inst

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008595179. Last updated year: 2026. Please use registration number 3008595179 when referencing this establishment in official correspondence.